TWI425936B - 用於減少移動假影之醫學感測器及其使用技術 - Google Patents

用於減少移動假影之醫學感測器及其使用技術 Download PDF

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TWI425936B
TWI425936B TW95136076A TW95136076A TWI425936B TW I425936 B TWI425936 B TW I425936B TW 95136076 A TW95136076 A TW 95136076A TW 95136076 A TW95136076 A TW 95136076A TW I425936 B TWI425936 B TW I425936B
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sensor
detector
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patient
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Carine Hoarau
Clark R Baker
Edward Karst
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Nellcor Puritan Bennett Inc
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6886—Monitoring or controlling distance between sensor and tissue
    • A—HUMAN NECESSITIES
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    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
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Description

用於減少移動假影之醫學感測器及其使用技術
本發明大體係關於醫學裝置，且更特定而言，係關於用於感測一病患之生理參數的感測器。
此部分意欲給讀者介紹可與本發明之各種態樣相關之技術的各種態樣，在下文描述及/或主張本發明之各種態樣。咸信此論述在給讀者提供背景資訊以便於本發明之各種態樣的更好理解方面有幫助。因此，應瞭解應照此閱讀此等闡述，且不作為先前技術之承認而閱讀。
在醫學領域中，醫生經常需要監視病患的某些生理特徵。因此，已經研發出非常多的裝置用於監視生理特徵。此等裝置給醫生及其他健康護理人員提供其需要的資訊以為其病患提供最佳的健康護理。結果，此等監視裝置已變成現代醫學一不可缺少之部分。
一種用於監視一病患之某些生理特徵之技術通常稱為脈搏血氧測定法，且基於脈搏血氧測定法技術而建置之裝置通常稱為脈搏血氧計。脈搏血氧測定法可用於量測各種血液流動特徵，諸如在動脈血中的血紅素之血氧飽和度、供應給組織的個別血液脈動之量，及/或對應於一病患之每次心跳之血液脈動的速率。事實上，脈搏血氧測定法中之"脈搏"表示在每一心動週期期間改變組織中動脈血之量的時間。
脈搏血氧計通常利用一非侵入性感測器，該非侵入性感 測器使電磁輻射(諸如光)穿過一病患之組織傳輸且光電偵測所傳輸之光在此組織中的吸收及散射。隨後可基於被吸收及被散射之光的量來計算以上生理特徵之一或多者。更特定言之，穿過組織之光通常經選擇具有一或多個波長，該等波長可以一與在組織中存在之血液成分之量相關的量被血液吸收或散射。被吸收及被散射之光之量測量隨後可用於使用各種演算法來估計組織中之血液成分的量。
脈搏血氧讀數量測組織中血液成分之量及類型之脈動動態變化。除動脈血之脈動以外的其他事件可導致光路徑、方向，及由感測器所偵測到之光量的調變，導致在此等量測中產生誤差。脈搏血氧測定法對移動敏感，且各種類型之移動可引起可使血液成分信號不明顯的假影。舉例而言，可藉由相對於組織移動感測器、藉由增加或減少感測器中之發射器與偵測器之間的實體距離、藉由相對於組織或相對於彼此改變發射器或偵測器之方向、藉由改變入射角及由光所探查之介面、藉由引導光學路徑穿過不同數量或不同類型之組織，或藉由擴張、壓縮或其他方式改變接近感測器之組織而引起移動假影。在脈搏血氧測定法常見用於病患監視之急診室、急救加護、重症加護，及外傷中心環境中，各種種類之移動假影之來源包括由健康護理工作人員移動病患或感測器、未經麻醉或能走動病患的身體移動、回應於疼痛及喪失神經控制的顫抖、病情發作、焦躁。此等移動時常具有類似於脈動之頻率成分，且可導致類似脈動或比脈動甚至更大的光學調變。
常見使用之兩類脈搏血氧感測器可由其使用模式來分類：拋棄式及可再用感測器。拋棄式感測器通常為可用黏合材料附著至病患之可撓性繃帶型結構，從而在病患之皮膚與感測器組件之間接提供觸。拋棄式感測器具有多個優勢，包括易於與病患貼服。拋棄式感測器之可撓特性進一步使其易於受到由感測器之機械變形所引起的移動假影之影響，改變了所偵測之光的量。常常為半剛性或剛性夾子型裝置之可再用感測器亦易受移動假影之影響，諸如由回應於病患移動之夾子局部打開引起的假影。兩類感測器可具有由感測器組件相對於彼此及相對於組織之實體移動引起的偵測到之光的調變。
有時在移動已發生之後，可由信號處理及濾波來處理移動假影以減輕移動之效應。然而，希望提供減少可導致移動假影之移動之發生的感測器。
在下文陳述與最初主張之發明相當之範疇的某些態樣。應理解，呈現此等態樣僅為了為讀者提供本發明可能採取之某些形式的簡短概述且此等態樣不意欲限制本發明之範疇。實際上，本發明可涵蓋可不在下文陳述之多種態樣。
提供一感測器，其包括一感測器體及安置於該感測器體之上的一發射器及一偵測器。感測器體經調適以在將感測器應用於一病患時，將發射器與偵測器相對於彼此固持在一大體上固定之光學距離上。
亦提供一脈搏血氧系統，其包括一脈搏血氧監視器及一 經調適以操作耦接至該監視器的脈搏血氧感測器。該感測器包括一感測器體，及安置於該感測器體之上的一發射器及一偵測器。感測器體經調適以在將感測器應用於一病患時，將發射器與偵測器相對於彼此固持在一大體上固定之光學距離上。
亦提供一種操作一感測器之方法，其包括固定一發射器與一偵測器之間相對於彼此之光學距離，藉此將該發射器及該偵測器安置於一感測器體上。
亦提供一種製造一感測器之方法，其包括提供一發射器及一偵測器安置在其上的感測器體，藉此該感測器體經調適以固持該發射器與該偵測器在一固定之光學距離上。
下文將描述本發明之一或多個特定實施例。為了簡要描述此等實施例，在說明書中並未描述實際實施例之所有特徵。應瞭解，任何此實際實施例之開發中，如在任何工程或設計項目中，必須做出大量與實施例相關之特定決定以達成開發者之特定目標，諸如遵從系統相關與商業相關之約束，此等約束在不同實施例之間係不同的。此外，應瞭解，此開發嘗試可能為複雜且耗時的，但對於具有此揭示內容之益處的一般技術者而言將為設計、生產，及製造中之一常規任務。
根據本技術，提供用於脈搏血氧測定法或利用分光光度法之其他應用的感測器，其在將感測器應用於病患時藉由固定一發射器與一偵測器之間的光學距離來減少移動假 影。舉例而言，在一實施例中，提供一貼服之感測器，其具有一經調適以在將感測器應用於病患時固持發射器與偵測器在一固定光學距離上的硬挺構件。在另一實施例中，提供一環形或部分環形感測器，其在將感測器應用於一病患之手指時保持一發射器與一偵測器之間有固定光學距離。此外，在一額外實施例中，提供一鉗狀感測器，其固持發射器與偵測器在一固定光學距離上。
在脈搏血氧測定法中之移動假影常常由脈搏血氧感測器相對於所光學探查之組織的移動而產生，該移動通常由病患移動引起。由於脈搏血氧測定法常常用於難於防止病患移動的環境中，因此需要提供用於減少移動對脈搏血氧量測之效應的機構。通常，歸因於使用中感測器之構造中的不當機械變化，當一感測器之發射器與偵測器之間之光學距離改變時，感測器易於受到移動假影之影響。
光學距離之改變可包括發射器及/或偵測器相對於組織或相對於彼此之位置或幾何形狀的任何改變。更特定言之，光學距離之改變可包含路徑長度之改變、發射器或偵測器相對於彼此之角度改變，及/或發射器或偵測器相對於組織之角度改變。舉例而言，病患之輕敲或擠壓移動可壓縮一可撓性繃帶感測器，從而減少發射器與偵測器之間的路徑長度。替代地，一輕敲或擠壓移動可經由夾子彈簧上之壓力部分地打開一夾子型感測器，從而增加發射器與偵測器之間的路徑長度。對於繃帶狀及鉗狀感測器兩者而言，急拉或撓曲移動可分離發射器與偵測器，從而增加光 學路徑長度。此外，以上移動之任一者可扭曲或彎曲感測器，引起發射器及/或偵測器之角度相對於感測器及相對於彼此改變。由於感測器通常即不全向發射光亦不全向偵測光；因此導致感測器組件之角度變化之任何移動可改變所偵測到光的量，且可強迫所偵測到之光穿過組織之不同部分。在任何情況下，歸因於移動引起光學路徑長度之變化可引起移動假影且使得所要的脈搏血氧信號不明顯。因此，需要使一感測器之發射器與偵測器相對於彼此固持在大體上固定之光學距離上。
藉由將感測器之發射器及偵測器相對於彼此固持在大體上固定的光學位置上，本文所提供之感測器限制了所偵測到的光可能發生之調變及所導致之量測誤差。藉由減少感測器之感測組件相對於彼此及相對於組織之位置的改變，此等感測器大體上減少了移動假影之發生。
緊記前述觀點，提供以下例示性感測器設計作為藉由保持一感測器10之一發射器與一偵測器之間的固定光學距離來減少移動假影之感測器的實例。應瞭解，根據本教示之一感測器10可經調適用於任何手指，且亦可經調適用於前額、耳垂，或其他感測器位點。舉例而言，一感測器10可為一鉗狀感測器，適用於病患耳垂或手指。或者，一感測器10可為用於手指或前額上之一繃帶狀或纏繞狀感測器。此外，應瞭解，一感測器10亦可包括黏著劑以幫助將感測元件固定至組織。在某些實施例中，黏著劑可包括感測器10之組織接觸表面上的黏著劑塗層。
根據本技術之某些實施例，提供用於脈搏血氧測定法或利用分光光度法之其他應用的感測器，其具有硬挺構件以減少發射器與偵測器之間的光學距離變化。舉例而言，圖1A說明一適用於病患手指之例示性發射型繃帶感測器。如圖1A所示，一感測器10A可具有一應用於一貼服感測器體14之硬挺構件12。可經由黏著劑或以其他方式將該硬挺構件12應用於一組織接觸表面16。由於硬挺構件12可與病患組織接觸，因此通常將其建構為沒有鋒利邊緣以便避免病患不適。硬挺構件12可具有窗口或其他開口(未圖示)，其形成適當尺寸以容納一發射器18及一偵測器20。可應用硬挺構件12使得窗口或開口與該發射器及該偵測器對齊以允許正常光發射及光偵測功能。感測器10A視情況可包括一用於將感測器附著至手指之光學透明黏接層22。通常黏接層22形成適當尺寸及形狀以覆蓋貼服感測器體14之組織接觸表面16。當將感測器10A應用於一病患之手指時，彎曲或以其他方式使硬挺構件成形以貼服手指。應用感測器10A使得發射器18及偵測器20位於手指之相對側上。在應用感測器10A之後，發射器18及偵測器20抵抗相對於彼此之移動。
硬挺構件12(及下文之硬挺構件36及42)可由任何適當材料來建構，用來在將感測器10A應用於一病患時將感測器之發射器及偵測器固持在大體上固定之光學距離上。舉例而言，一適當硬挺構件12可為金屬、塑膠或聚合物，或硬紙板。在某些實施例中，適當金屬包括鋁或黃銅。硬挺構 件12可為帶形、線形或網目形，其可容易地經調適用於一貼服感測器體14。硬挺構件12可經調適以易於彎曲、成形、啟動、或應用至一貼服感測器體14以便將一發射器及一偵測器固持在一大體上固定之光學距離上。硬挺構件12可形成適當尺寸以大體上覆蓋組織接觸表面16之大部分，或由於關於成本或總感測器重量之原因，可形成適當尺寸以形成大體在環繞發射器18及偵測器20之區域中的條帶。
在某些實施例中，將一硬挺構件應用於在正常使用期間不接觸病患之組織之一感測器表面上為有利的。舉例而言，某些病患可對金屬敏感，且因此在某些情況下，需要限制皮膚與一金屬硬挺構件接觸的量。對於彼等病患，如圖2所展示之感測器10B可為適當的。圖2展示一感測器10B之一實施例，其中將一黃銅硬挺構件24應用於在感測器10B之正常使用期間不接觸組織之表面26。將該黃銅硬挺構件24沿連接一發射器28及一偵測器30之一虛軸應用於表面26。當將感測器10B應用於一病患之手指時，彎曲黃銅硬挺構件24以貼服手指而不與病患之組織接觸。在一替代性實施例(未圖示)中，感測器10B經調適以以一反射模式操作。將發射器28及偵測器30定位在感測器體上使得在應用於一病患之手指時，其處於並排狀態。
在某些實施例中，一硬挺構件可與貼服感測器體整體建構，或可為一獨立結構。更特定言之，在如圖3A所展示之實施例中，一感測器10C具有一位於貼服感測器體34內之封閉腔32，可將一硬挺構件36整合至或嵌入至該封閉腔32 中。或者，在某些實施例中，將硬挺構件在使用時應用於感測器可為有利的。圖3B說明感測器10D，其中貼服感測器體38具有一沿感測器體延伸以提供一開口之開口腔40，可在將感測器10D應用至一病患時用手將一可移除硬挺構件42插入至該開口中。在用後丟棄感測器10D之前，可將可移除硬挺構件42移除且儲存以備再用。具有一未整合至感測器10D之可再用可移除硬挺構件42可減少在運送及傳送中感應器的重量，且從而可提供一定成本優勢。
在圖4A所展示之一替代性實施例中，具有一在貼服感測器體48中之一封閉腔46內的嵌入式硬挺構件44之感測器10E可經調適以以反射模式操作，使得在將該感測器應用於一病患時，發射器50及偵測器52處於並排狀態。硬挺構件44包括一安置相鄰發射器50及偵測器52之區域中的剛性部分45及一更具可撓性部分47。因此，當將感測器10E應用於一病患時，硬挺構件44之可撓性部分47允許感測器10E被彎曲包圍手指同時給貼服感測器體48增加穩定性。環繞發射器50及偵測器52之剛性部分45可固定感測元件之幾何形狀，從而大體上減少其相對於彼此移動之能力。在一替代性實施例中，圖4B說明反射感測器10F，其中貼服感測器體54包括一環繞發射器60及偵測器62之剛性部分57。可將該剛性部分嵌入至感測器體54中，或可將其安置於感測器體54之組織接觸表面上。圖4C說明感測器10F之一替代性實施例，其中貼服感測器體54具有一沿感測器體延伸以提供一開口之開口腔56，可在將感測器10F應用至 一病患時用手將一可撓性構件58插入至該開口中。剛性部分57與可移除可撓性構件58分離。因此，若一健康護理工作人員覺得額外感測器10F穩定性可為有利的，則可將可撓性構件58插入至感測器10F中。當將感測器應用於病患時，發射器60及偵測器62在組織之相同側上處於並排狀態。
硬挺構件不必為固體，而亦可為穩定發射器與偵測器之間之光學距離的流體或其他非固體材料。在另一實施例中，圖5A展示一感測器10G，其中貼服感測器體64含有經調適以固持流體68之囊袋66。流體68可為一液體、凝膠、氣體，或其任何適當混合物。設想氣體或液體之硬挺品質可藉由在囊袋66中達成一定壓力來實現。通常，設想應使用流體68使囊袋66完全膨脹或大部分膨脹以將發射器70與偵測器72固持在一固定光學距離上。在某些實施例中，在一段時間之後，液體或凝膠可變硬。在以上實施例中所描述之流體66可為在將感測器10G應用於病患之手指時，用來將一發射器70與一偵測器72固持在一大體上固定光學距離上的任何適當流體。在某些實施例中，流體可為空氣或其他氣體及氣體混合物。在其他實施例中，流體可為水。
在某些實施例中，由於關於成本、製造簡便，及總感測器重量的原因，需要使用一氣體或氣體混合物。在圖5B中，修改感測器10G以包括一閥門74或另一適當開口或氣體注入位點。可在該閥門74處於封閉位置且囊袋66大體上為空且乾癟時，將感測器應用於病患之手指。在將感測器 10G應用至手指之後，打開閥門74以允許氣體流動至囊袋66中，其使感測器10G變得硬挺以固定發射器70與偵測器72之間的距離。在其他實施例中，閥門74可為一液體或環氧樹脂注入位點。
在圖6中說明另一實施例，其中可在將感測器應用至一病患時隨即啟動含流體硬挺構件。圖6描繪一感測器10H，其具有填充第一材料80之一第一腔室78，及填充第二材料84之第二腔室82。一障壁86分離第一腔室78及第二腔室82。該障壁86能夠在將感測器82應用於一病患時被破壞。在破壞障壁86之後，第一材料80及第二材料84將混合且形成能夠變硬之組合物，從而穩定發射器88與偵測器90之間的光學距離。舉例而言，第一材料80可為水泥或石膏，且第二材料84可為水。在另一實施例中，第一材料80可為環氧樹脂。在另一實施例中，第一材料80可為兩部分環氧樹脂之一個部分，其中該環氧樹脂之一第一部分(諸如基質)為第一材料80，且環氧樹脂之一第二部分(諸如催化劑或硬化劑)為第二材料84。可用於感測器10H之兩部分環氧樹脂包括Loctite® 30680(可購自Henkel,Rocky Hill,CT)、Blu-Mousse®(可購自Parkell,Inc.,Farmindale,NY)、來自DMG之LuxaCore® Smartmix dual(可購自DMG,Englewood,NJ)，及Exaflex(可購自GC America,Inc.,Alsip,IL)。
在替代性實施例中，可在曝露於空氣或光、處於與皮膚接觸、附著至感測器位點、貼服置於感測器位點、經受特定環境條件(例如，當曝露於體溫或室溫)、經受特定化學 反應、由軟體程式化，或經受外力(例如，來自由感測器所探查之組織之力)時有條件地啟動一硬挺構件。舉例而言，一有條件地啟動之硬挺構件可為一在曝露於氧或水蒸氣時隨即形成一剛性沉澱物之真空包裝的聚合物。在其他實施例中，硬挺構件可包括一光固化黏著劑，諸如Loctite® Flashcure-4305(可購自Henkel,Rocky Hill,CT)。在另一實施例中，硬挺構件可包括經受一化學硬化(諸如曝露於晶種時的結晶)之材料。一種此材料為曝露於醋酸鈉晶體之過飽和醋酸鈉溶液。用於形成有條件地啟動之硬挺構件之其他適當材料包括(例如)可在曝露於空氣時隨即膨脹及硬挺的聚胺基甲酸酯及聚苯乙烯發泡體。
圖7說明本發明之一替代性實施例，其中硬挺構件為一可應用於一感測器(通常標識為一感測器10)之套筒92，以便在應用感測器10之後機械穩定發射器94與偵測器96之間的距離。套筒94可具有內部凸塊或突起(諸如發泡體凸塊95)，用來抵抗外力，吸收震動且緩衝感測器10。
儘管先前論述之實施例已描述貼服感測器，但亦展望可藉由組態相對剛性之感測器來將發射器與偵測器固持在一固定光學距離上來實現類似優勢。舉例而言，圖8A展示經調適以應用於一病患之手指的剛性環形感測器10I。感測器10I經調適以滑動至一病患手指上，且可由繃帶或黏著劑進一步固定。感測器10I之剛性用來將發射器98與偵測器100固持在一固定光學距離上。在另一實施例(未圖示)中，感測器10G可在一鉸鏈處打開且亦具有一插銷、搭 扣，或其他封閉機構。如圖8B中所展示，可用一帶102或其他調整機構來調整環形感測器10I以便緊密貼服手指。
圖9展示一可置放於手指上且自固定或由繃帶或其他部件固定之部分環形感測器10J。感測器10J通常為至少半環形以便在手指上提供充分的夾緊。一發射器104及一偵測器106經配置使得當將感測器應用於手指時，其將在手指之相對側上。
環形或部分環形感測器(例如，感測器10I及10J)可由塑膠、金屬、硬紙板，或任何適當彈性材料來建構。設想感測器10I及10J可形成適當尺寸以近似與珠寶戒指之輪廓相關。或者，感測器10I及10J可形成適當尺寸近似與第一指關節之尺寸相關，使得當將感測器10I及10J應用於手指時，手指之指甲區通常由感測器覆蓋，而感測器不干擾指關節之撓曲或彎曲。
在另一實施例中，提供經調適用於一手指或一耳垂上之可再用夾子型感測器，其在使用一間隔器的情況下將一發射器與偵測器固持在一固定光學距離上。在圖10中展示經調適用於一病患耳垂之此感測器，其說明具有可朝向彼此或遠離彼此移動之一第一部分108及一第二部分110之一感測器10K。第一部分108及第二部分110每一者皆能夠嚙合一由一螺紋銷114控制之間隔器112。在螺紋銷114沿一有角度(angled)軌跡移動間隔器112時，間隔器112控制第一部分88與第二部分110之間的距離。第一部分108具有一安置於組織接觸表面上之發射器116且第二部分110具有安置 於組織接觸表面上之偵測器118。當將感測器10K應用於一耳垂時，間隔器112可經調整使得感測器10K在保持第一部分108與第二部分110之間之一固定光學距離的同時將所要量之張力提供至耳垂。
在圖11A中描繪具有一間隔器之一鉗狀感測器10L之一替代性實施例。如圖所展示，感測器10L之一第一部分120及一第二部分122在應用至一耳垂之後可用一可移除間隔器124固定在適當位置中。可移除間隔器124滑動入第一部分120與第二部分122之間的間隔126中且防止第一部分120與第二部分122相對於彼此移動。如圖11B所展示，可移除間隔器具有凹槽128及130，第一部分120及第二部分122形成適當尺寸之區可滑動至該等凹槽中。當第一部分120及第二部分122固定在凹槽128及130中時，其不能相對於彼此移動。展示可移除間隔器124具有一有角度輪廓，但可以用來在嚙合間隔器124時將第一部分120與第二部分122固持在一固定光學距離上之任何適當組態來形成適當形狀尺寸。可進一步將可移除間隔器124用磁性固定在適當位置中(未圖示)。
或者，在圖12中，說明一感測器10M，其中由一滑動銷136來控制鉗狀感測器10M之一第一部分132與一第二部分134之間的距離。滑動銷136及第一部分132及第二部分114部分地封閉在一外殼137內。第一部分132及第二部分134具有能夠嚙合滑動銷136之附著槽138。因此，當拉動滑動銷136時，第一部分132及第二部分134朝向彼此移動。當 推動滑動銷136時，第一部分132及第二部分134遠離彼此移動。第一部分132及第二部分134可經調適以收容一發射器及一偵測器(未圖示)。為了將感測器10M應用於病患，將滑動銷136推動至外殼137中以增加第一部分132與第二部分134之間的距離以便容納病患之組織。隨後可將滑動銷136推動入外殼137中直至達到感測器10M在病患之組織上的所要壓力。
如圖13所說明，一感測器(一般說明為感測器10)可與一脈搏血氧監視器140結合使用。應瞭解，感測器10之電纜142可耦接至監視器140或其可耦接至傳輸裝置(未圖示)以促進感測器10與監視器140之間的無線傳輸。監視器140可為任何適當脈搏血氧計，諸如可購自Nellcor Puritan Bennett Inc.的彼等脈搏血氧計。此外，為了升級由監視器140提供之習知脈搏血氧測定法以提供額外之功能，監視器140可經由連接至一感測器輸入埠之電纜146或經由連接至一數位通信埠之電纜148來耦接至多參數病患監視器144。
感測器10包括可為任何適當類型之一發射器150及一偵測器152。舉例而言，發射器150可為經調適以傳輸紅色至紅外線範圍中之一或多個波長之光的一或多個發光二極體，且偵測器152可為經選擇以接收自發射器150所發射之範圍或(多個)範圍中之光的一或多個光偵測器。或者，一發射器150亦可為一雷射二極體或一垂直共振腔面射型雷射(VCSEL)。發射器150及偵測器152亦可包括光纖感測元 件。發射器150可包括一寬頻帶或"白光"源，在此情況下偵測器可包括用於選擇特定波長之多種元件之任一者，諸如反射性或折射性元件或干涉計。此等種類之發射器及/或偵測器通常可經由光纖耦接至剛性或剛性化之感測器。或者，一感測器10可感測來自發射至組織中之光、自組織所偵測到的不同波長的光。此等感測器可經調適以感測螢光、磷光、拉曼(Raman)散射、瑞立(Rayleigh)散射及多光子事件或光聲效應。對於使用發射或反射型感測器之脈搏血氧應用，病患之動脈血之氧飽和度可使用兩個或兩個以上波長(最常見紅色及近紅外線波長)之光來確定。類似地，在其他應用中，組織水份(或與其他體液相關之度量)或在一含水環境中之一或多種生物化學成分的濃度可使用兩個或兩個以上波長(最常見為在約1000nm至約2500nm之間的近紅外線波長)之光來量測。應理解，如本文所使用，術語"光"可表示超音波、無線電、微波、毫米波、紅外線、可見光、紫外線、伽瑪射線或X射線電磁輻射之一或多者，且亦包括無線電、微波、紅外線、可見光、紫外線或X射線光譜內之任何波長。
發射器150及偵測器152可安置於一感測器體154上，感測器體154可由任何適當材料製成，諸如塑膠、發泡體、編織材料，或紙。或者，發射器150及偵測器152可遠端定位且使用光纖光學耦接至感測器10。在所描繪之實施例中，感測器10耦接至電纜142，其負責自感測器10之發射器150及偵測器152傳輸電信號及/或光學信號及傳輸電信 號及/或光學信號至感測器10之發射器150及偵測器152。電纜142可永久地耦接至感測器10，或其可在感測器10為拋棄式的情況下可移除地耦接至感測器10，後者替代方式更有用且更符合成本效益。
感測器10可為"發射型"感測器。發射型感測器包括通常置放於感測器位點之相對側上的發射器150及偵測器152。舉例而言，若感測器位點為一指尖，則感測器10定位於病患之指尖上使得發射器150及偵測器152位於病患之指甲床之任一側。換言之，感測器10經定位使得發射器150定位於病患之指甲上且偵測器152經定位與發射器150相對成180°，在病患之指腹上。在操作期間，發射器150穿過病患之指尖發出一或多個波長之光且偵測器152所接收的光被處理以確定病患之各種生理特徵。在本文所論述之實施例之每一者中，應理解，可互換發射器150與偵測器152之位置。舉例而言，偵測器152可定位於手指之頂部且發射器150可位於手指之下部。在任一配置中，感測器10將以大體上相同之方式執行功能。
反射型感測器亦藉由將光發射至組織中且偵測由組織發射及散射之光來操作。然而，反射型感測器包括通常置放於感測器位點之相同側上的發射器150及偵測器152。舉例而言，反射型感測器可置放於一病患之指尖或前額上使得發射器150與偵測器152處於並排之狀態。反射型感測器偵測被散射回偵測器152之光子。感測器10亦可為"發射反射型(transflectance)"感測器，諸如可包在嬰兒之腳跟之一部 分中的感測器。
雖然本發明可進行各種修正及替換形式，但已經由圖式中之實例來展示且已在本文中詳細描述特定實施例。然而，應理解，本發明不意欲限制為所揭示之特定形式。實際上，本技術不僅可應用於血氧飽和度之量測，而且此等技術可用於使用脈搏血氧測定法之原理之其他血液及/或組織成分的量測及/或分析。舉例而言，使用相同、不同，或額外之波長，本技術可用於一氧化碳血紅素、變性血紅素、總血紅素、部分血紅素、血管內染色劑，及/或水含量之量測及/或分析。事實上，本發明意欲覆蓋屬於以下所附申請專利範圍所界定之本發明之精神及範疇內的所有修正、均等物，及替代形式。
10‧‧‧感測器
10A‧‧‧感測器
10B‧‧‧感測器
10C‧‧‧感測器
10D‧‧‧感測器
10E‧‧‧感測器
10F‧‧‧感測器
10G‧‧‧感測器
10H‧‧‧感測器
10I‧‧‧感測器
10J‧‧‧感測器
10K‧‧‧感測器
10L‧‧‧感測器
10M‧‧‧感測器
12‧‧‧硬挺構件
14‧‧‧感測器體
16‧‧‧組織接觸表面
18‧‧‧發射器
20‧‧‧偵測器
22‧‧‧黏接層
24‧‧‧黃銅硬挺構件
26‧‧‧表面
28‧‧‧發射器
30‧‧‧偵測器
32‧‧‧封閉腔
34‧‧‧感測器體
36‧‧‧硬挺構件
38‧‧‧感測器體
40‧‧‧開口腔
42‧‧‧可移除硬挺構件
44‧‧‧硬挺構件
45‧‧‧剛性部分
46‧‧‧封閉腔
47‧‧‧更具可撓性部分
48‧‧‧感測器體
50‧‧‧發射器
52‧‧‧偵測器
54‧‧‧感測器體
56‧‧‧開口腔
57‧‧‧剛性部分
58‧‧‧可撓性構件
60‧‧‧發射器
62‧‧‧偵測器
64‧‧‧感測器體
66‧‧‧囊袋
68‧‧‧流體
70‧‧‧發射器
72‧‧‧偵測器
74‧‧‧閥門
78‧‧‧第一腔室
80‧‧‧第一材料
82‧‧‧第二腔室
84‧‧‧第二材料
86‧‧‧障壁
88‧‧‧發射器
90‧‧‧偵測器
92‧‧‧套筒
94‧‧‧發射器
95‧‧‧發泡體凸塊
96‧‧‧偵測器
98‧‧‧發射器
100‧‧‧偵測器
102‧‧‧帶
104‧‧‧發射器
106‧‧‧偵測器
108‧‧‧第一部分
110‧‧‧第二部分
112‧‧‧間隔器
114‧‧‧螺紋銷
116‧‧‧發射器
118‧‧‧偵測器
120‧‧‧第一部分
122‧‧‧第二部分
124‧‧‧間隔器
126‧‧‧間隔
128‧‧‧凹槽
130‧‧‧凹槽
132‧‧‧第一部分
134‧‧‧第二部分
136‧‧‧滑動銷
137‧‧‧外殼
138‧‧‧附著槽
140‧‧‧脈搏血氧監視器
142‧‧‧電纜
144‧‧‧多參數病患監視器
146‧‧‧電纜
148‧‧‧電纜
150‧‧‧發射器
152‧‧‧偵測器
154‧‧‧感測器體
圖1說明一例示性繃帶狀脈搏血氧感測器的透視圖，在感測器體之組織接觸側上具有一硬挺構件；圖2說明一例示性繃帶狀脈搏血氧感測器的透視圖，具有應用於在正常使用期間不接觸病患之組織之感測器體的表面的一黃銅硬挺構件；圖3A說明展示具有一嵌入式硬挺構件之一例示性繃帶狀脈搏血氧感測器之內部的圖；圖3B說明具有一嵌入式可移除硬挺構件之一例示性繃帶狀脈搏血氧感測器之透視圖；圖4A說明展示具有一嵌入式硬挺構件之一例示性反射繃帶狀脈搏血氧感測器的內部之圖，該嵌入式硬挺構件包括 一環繞發射器及偵測器之剛性部分及一可撓性部分；圖4B說明展示一例示性反射繃帶狀脈搏血氧感測器的圖，具有一環繞發射器及偵測器之硬挺構件；圖4C說明一例示性反射繃帶狀脈搏血氧感測器的透視圖，具有環繞發射器及偵測器之一剛性部分及一可撓性嵌入式可移除硬挺構件；圖5A說明具有一流體填充腔室之例示性繃帶狀脈搏血氧感測器之透視圖；圖5B說明圖5A之脈搏血氧感測器之透視圖，其中流體填充腔室包括一閥門；圖6說明一例示性繃帶狀脈搏血氧感測器的透視圖，具有由一易破障蔽分離之兩個流體填充腔室；圖7說明根據本發明一例示性脈搏血氧感測器的透視圖，具有一可移除剛性套筒；圖8A說明根據本發明之例示性環形脈搏血氧感測器的透視圖；圖8B說明具有一調整帶之圖8A之脈搏血氧感測器的透視圖；圖9說明根據本發明之例示性部分環形脈搏血氧感測器之一實施例；圖10說明一例示性鉗狀脈搏血氧感測器之橫截面圖，具有一移動以調整夾子之兩個部分之間的距離的間隔器；圖11A說明根據本發明之例示性鉗狀脈搏血氧感測器的透視圖，具有一可移除間隔器； 圖11B為圖11A之可移除間隔器之一透視圖；圖12說明一例示性鉗狀脈搏血氧感測器之透視圖，其中用一滑動銷調整夾子之兩個部分；及圖13說明耦接至一多參數病患監視器及根據本發明之實施例之感測器的脈搏血氧系統。
10A‧‧‧感測器
12‧‧‧硬挺構件
14‧‧‧感測器體
16‧‧‧組織接觸表面
18‧‧‧發射器
20‧‧‧偵測器
22‧‧‧黏接層

Claims (44)

  1. 一種感測器，其包含：一貼服的感測器體；一可移除的硬挺構件，其安置於該感測器體中的一開口腔中及一發射器及一偵測器，其安置於該硬挺構件上，其中該發射器及該偵測器經調適而運作於一反射模式中，且其中該感測器體經調適以在將該感測器應用於一病患時，將該發射器與該偵測器相對於彼此固持在一大體上固定之光學距離上。
  2. 如請求項1之感測器，其中該感測器包含一血液成分感測器或一組織成分感測器中之至少一者。
  3. 如請求項1之感測器，其中該感測器包含一脈搏血氧感測器或一用於量測一水份之感測器中之至少一者。
  4. 如請求項1之感測器，其中該感測器包含一一氧化碳血紅素感測器或一變性血紅素感測器中之至少一者。
  5. 如請求項1之感測器，其中該感測器經調適用於子宮內用途。
  6. 如請求項1之感測器，其中該硬挺構件係嵌入在該感測器體內。
  7. 如請求項1之感測器，其中該硬挺構件包含一金屬或一剛性聚合材料。
  8. 一種感測器，其包含：一大體上環形或部分環形剛性感測器體，其經組態以 將該感測器保持於一病人的手指上，其中該感測器體形成該感測器之一組織接觸表面；及一發射器及一偵測器，其安置於該感測器體之該組織接觸表面，其中該感測器體經調適以當該感測器貼附於一病人時且當該感測器感受一外部輕敲力量或當該手指施加一撓曲力量至該感測器時，將該發射器及該偵測器相對於彼此且相對於該病人手指固持於一固定光學距離。
  9. 如請求項8之感測器，其中該感測器體經調適具有一可調整直徑。
  10. 如請求項8之感測器，其中該感測器體包含一調整帶。
  11. 如請求項10之感測器，其中該調整帶包含複數個凹口，該等凹口經調適以固定該感測器體之該直徑。
  12. 如請求項8之感測器，其中該感測器體包含一鉸鏈。
  13. 如請求項8之感測器，其中該發射器及該偵測器經調適以運作於一發射模式。
  14. 如請求項8之感測器，其中該發射器及該偵測器經調適以運作於一反射模式。
  15. 如請求項第8項之感測器，其中該感測器體經調適以在將該感測器體應用於一手指之一指甲區域時，允許一相鄰手指關節之撓曲。
  16. 如請求項第8項之感測器，其中該感測器體包含一環，將該環經調適以在該感測器體應用於一手指或腳趾時，需許一相鄰手指關節之撓曲。
  17. 如請求項第8項之感測器，其中一黏著劑係置於該感測器體上以將該感測器體耦接至該手指。
  18. 一種感測器，其包含：一發射器及一偵測器，其安置於一貼服感測器體上；一第一腔，其安置於該感測器體中或該感測器體上，該第一腔包含一第一材料；以及一第二腔，其安置於該感測器體中或該感測器體上，該第二腔包含一第二材料，其中該第一材料在曝露至該第二材料時變硬。
  19. 如請求項18之感測器，其包含在該第一腔與該第二腔之間的一易破障蔽。
  20. 如請求項18之感測器，其中該第一材料包含水泥或熟石膏，且該第二材料包含水。
  21. 如請求項18之感測器，其中該第一材料包含一兩部分環氧化物的一部分。
  22. 一種脈搏血氧系統，其包含：一脈搏血氧監視器；及一脈搏血氧感測器，其經調適以操作耦接至該監視器，該感測器包含：一貼服感測器體；一可移除硬挺構件，其安置於該感測器體中的一開口腔中；以及一發射器及一偵測器，其安置於該硬挺構件上，其中該發射器及該偵測器經調適以運作於一反射模式中，且 其中該感測器經調適以在將該感測器應用於一病患時，將該發射器與偵測器相對於彼此固持在一大體上固定之光學距離上。
  23. 如請求項22之系統，其中該感測器包含一組織成分感測器。
  24. 如請求項22之系統，其中該感測器包含一用於量測一水份之感測器。
  25. 如請求項22之系統，其中該感測器包含一一氧化碳血紅素感測器或一變性血紅素感測器中之至少一者。
  26. 如請求項22之系統，其中該感測器經調適用於子宮內用途。
  27. 如請求項22之系統，其中該硬挺構件係嵌入在該貼服感測器體內。
  28. 如請求項22之系統，其中該硬挺構件包含一金屬或一剛性聚合材料。
  29. 一種脈搏血氧系統，其包含：一脈博血氧監視器；及一脈搏血氧感測器，其經調適以操作耦接至該監視器，該感測器包含：一大體上環形或部分環形感測器體，其經組態以將該感測器保持於一病人的手指上，其中該感測器體形成該感測器之一組織接觸表面；及一發射器及一偵測器，其安置於該感測器體之該組織接觸表面，其中該感測器體經調適以當該感測器貼附 於一病人時且當該手指施加一撓曲力量於該感測器時或當一外部輕敲力量施加於該感測器時，將該發射器及該偵測器相對於彼此且相對於該病人的手指固持於一固定光學距離。
  30. 如請求項29之系統，其中該發射器及該偵測器經調適以運作於發射模式中。
  31. 如請求項29之系統，其中該發射器及該偵測器經調適以運作於反射模式中。
  32. 如請求項29之系統，其中該感測器體經調適具有一可調整直徑。
  33. 如請求項29之系統，其中該感測器體包含一調整帶。
  34. 如請求項29之系統，其中該感測器體包含一鉸鏈。
  35. 一種製造一脈搏血氧感測器的方法，其包含：提供一貼服感測器體，其經調適用於在一病人的手指上使用；提供一可移除硬挺構件，其安置於該感測器體中的一開口腔中；以及提供一發射器及一偵測器，其安置於該硬挺構件上，其中該發射器及該偵測器經調適以運作於反射模式中，且其中該感測體經調適以當該感測器應用於一病人時將該發射器及該偵測器相對於彼此固持於一大體上固定的光學距離。
  36. 如請求項35之方法，其中該感測器包含一血液成分感測器或一組織成分感測器中之至少一者。
  37. 如請求項35之方法，其中該感測器包含一脈博血氧感測器或一用於量測一水份之感測器中之至少一者。
  38. 如請求項35之方法，其中該感測器包含一一氧化碳血紅素感測器或一變性血紅素感測器中之至少一者。
  39. 如請求項35之系統，其中該硬挺構件係嵌入在該貼服感測器體內。
  40. 一種製造一脈博血氧感測器的方法，該脈博血氧感測器經調適以應用於一手指，該方法包含：提供一環形或部分環形剛性感測器體，其經組態以將該感測器保持於該手指上且其中一發射器及一偵測器係安置於該感測器體之一組織接觸表面，其中該感測器體經調適以當該感測器感受一外部輕敲力量或當該手指施加一撓曲力量於該感測器時，將該發射器與該偵測器相對於彼此且相對於該手指固持於一固定之光學距離上。
  41. 如請求項40之方法，其包含：提供一調整帶。
  42. 如請求項40之方法，其包含：在該感測器體中提供一鉸鏈。
  43. 如請求項40之方法，其中該發射器及該偵測器經調適以運作於發射模式中。
  44. 如請求項40之方法，其中該發射器及該偵測器經調適以運作於反射模式中。
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